Heart disease is the leading cause of death worldwide, and statins are a vital medication against it – but they are notoriously unpopular, leading to poor adherence. Investigators from Brigham and Women’s Hospital conducted the first population-based study on patients’ nonacceptance of statin therapy recommendations, and published their results in JAMA Network Open.
The study found that in patients at high risk of developing cardiovascular disease, over 20% refused to take statin medications. They were particularly surprised to see that women were about 20% more likely than men to refuse statin therapy when it was first suggested by their physician, and 50% more likely than men to never accept the recommendation. The study also showed that all patients who refused statin therapy developed higher LDL cholesterol levels, likely increasing their risk even further.
“Our study highlights the alarming number of patients who refuse statins and signals that physicians must have discussions with patients about why,” says Alex Turchin, MD, MS, an associate professor at Harvard Medical School and director of quality in the Brigham’s Division of Endocrinology, Diabetes, and Hypertension. “We need to better understand what our patients’ preferences are and to be able to provide more patient-centered care.”
After Turchin began noticing that many of his patients with high cholesterol, including those with diabetes, were opting not to take safe and beneficial medications like statins that can lower cholesterol and bring down the risk of heart attack and stroke, he developed a system to more closely study the phenomenon by analysing the text of provider notes.
The study focused on high-risk patients who either had coronary artery or vascular disease, diabetes, very high cholesterol, or had suffered a stroke. All were recommended statin medications by their physicians to reduce their risk of heart attack and stroke and reduce cholesterol levels. The retrospective study included more than 24 000 patients who were seen at Mass General Brigham between January 1, 2000, and December 31, 2018.
“Even in this higher-risk patient population, so many people did not accept statin therapy,” Turchin said. The study found that while about two-thirds of the patients who were being recommended statin therapy eventually tried it, about one-third never did. And it took three times as long for people in the study who initially said no to taking statin medications to reduce their LDL cholesterol levels to less than 100, compared to people who initially said yes.
The study’s biggest surprise, however, was the much higher rate of refusal by women than men. Turchin and his colleagues wonder if this might be due in part to a false misconception that heart disease impacts men more than women, and plan to further research the reasons underlying these results.
“Ultimately, we need to talk to our patients and find out in more detail why they would prefer not to take statins,” Turchin says. He is currently looking at the impacts of nonacceptance of statin therapy on outcomes that matter to most to patients including heart attacks, strokes, and death. “I think people underestimate how much of a difference modern medicine has made in extending people’s lives, and their quality of life, and medications can play a big role in that.”
From back pain to achy joints, musculoskeletal pain, while common, can be life-changing and debilitating. A recent study published by the Journal of Biomechanical Engineering reveals that, in spinal degeneration, stiffening ligaments can alter mechanical loading on joints resulting in facet joint pain. This research may help to develop new treatments for musculoskeletal pain.
“Our goal is to understand the degeneration process of musculoskeletal tissues, including cartilage, ligaments, and intervertebral discs, using advanced mechanics techniques,” says Jill Middendorf, an assistant professor of mechanical engineering at Johns Hopkins University. “If we understand why this process is happening, we hope to translate our findings into new methods to repair damaged tissues and prevent more pain,”
Middendorf and collaborators sought to understand how the soft tissues of the spine change as spinal discs break down, or degenerate, over time.
Specifically, they looked at the facet capsular ligament, a soft tissue that holds the two sides of the facet joint together and is thought to be a common cause of lower back pain. Previous studies suggest this could be related to mechanical changes that occur in this ligament during spinal degeneration, though it’s not clear exactly why, Middendorf says.
To find out, the team extracted facet capsular ligaments from cadaver spines and ran experiments to measure the ligament’s mechanical properties, like stress and strain, under different loading conditions. By comparing MRI images of the spine and their experimental results, the team discovered that the tissues in the ligament became stiffer as the spine degenerated.
The researchers think this increased stiffness causes altered loading in surrounding tissues, and may explain why some people experience facet joint pain.
“Here we show that there is a correlation between the mechanics of the ligament and spine degeneration, which brings us even closer to being able determine if this ligament is causing pain or if it’s some other part of the spine,” Middendorf says.
With insights gathered from their tissue experiments, researchers in Middendorf’s lab plan to work next on furthering our understanding of spinal degeneration and creating engineered musculoskeletal tissue that can be implanted to replace damaged or diseased tissue.
However, when it comes to pain, answers aren’t always easy to find.
“‘One of the challenges associated with diagnosing and treating spine pain is determining the source of the pain,” Middendorf says. “But we can understand more about the causes and mechanisms of tissue damage, and that means we will someday be able to reverse engineer a solution.”
Following pharmaceutical company Eli Lilly’s much-lauded move to cut US prices for its insulin products, US President Joe Biden is calling on other drugmakers to make similar reductions for the vital medication.
According to Euronews, Lilly is directly slashing its insulin prices by about 70%, since many patients cannot access discounts, and is capping consumer costs at US$35 (R635) a month.
Biden is driving a push for cheaper insulin, signing a law that capped insulin at US$35 a month for senior citizens on Medicare, and urged companies to lower prices on their own. “For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions,” Biden said.
“Insulin costs less than US$10 to make, but Americans are sometimes forced to pay over US$300 for it. It’s flat wrong”.
Biden has called for a national cap on insulin prices, but his current Act does not extend to that.
A Lilly press release revealed that the price of Humalog® (insulin lispro injection) 100 units/mL (Lilly’s most commonly prescribed insulin) and Humulin® (insulin human) injection 100 units/mL by would be cut by 70%. This price change would take effect around the end 2023. Lilly also said it would cut the price for the generic Lispro to US$25 a vial starting in May. In South Africa, a Humulin® 10mL vial costs R525.28, or US$28.08, according to Health-e’s medicine price registry.
Lilly CEO David Ricks said his company was bringing the changes as not all patients could benefit through discounts through insurers or pharmacy benefit managers.
“We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don’t use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable,” said Ricks. “For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won’t stop until all people with diabetes are in control of their disease and can get the insulin they need.”
Since insurers and pharmacies will take a while to implement the price cuts, Lilly will immediately cap monthly out-of-pocket costs at $35 for people who are not covered by Medicare’s prescription drug programme.
Child obesity is linked to increased risk of developing diabetes in adulthood, both autoimmune forms of diabetes and different forms of type 2 diabetes, according to a new study in the journal Diabetologia. The risk of developing the most insulin-resistant form of diabetes is, for example, three times as high in children with obesity.
Diabetes affects ~7% of the adult population and is one of the world’s fasted growing diseases. It has traditionally been divided into two subgroups – type 1 and type 2 diabetes – but research suggests that this is a simplification.
In 2018, a Swedish study identified five subgroups of adult-onset diabetes, characterised by auto-immunity, severe insulin deficiency, serious insulin resistance, overweight and advanced age.
One way the researchers say that the relevance of these subgroups can be highlighted is to examine if the influence of known risk factors for diabetes differs between the proposed diabetes types.
“Our study is one of the first attempts to find this out,” says the study’s first author Yuxia Wei, doctoral student at Karolinska Institutet. “Childhood obesity has been linked to several chronic diseases, but has never been studied in relation to the recently proposed diabetes subgroups.”
Wanted to investigate the effect of child obesity
The purpose of the present study was therefore to see if the effect of childhood obesity differs. The researchers used a method called Mendelian randomisation, which uses genetic information to study the correlation between an environmental risk factor and disease risk while taking into account the impact of other risk factors.
Basing their analysis on genetic data from over 400 000 UK Biobank participants, the researchers compared children who considered themselves larger than other children with children who rated their weight as normal.
The results showed that overweight/obesity in childhood was linked to a 62% higher risk of autoimmune diabetes, a doubling of the risk of diabetes characterised by insulin deficiency, almost a tripling of the risk of the most insulin-resistant form of diabetes and a seven-times higher risk of the form of diabetes primarily characterised by overweight.
“Our analyses show that children who are larger than others are more likely to develop four of the five proposed new subgroups of adult-onset diabetes,” says Wei. “In other words, obesity in childhood seems to be a risk factor in effectively all types of adult diabetes, with the exception of age-related diabetes. This underscores how important it is to prevent obesity in children since it can have lasting effects on their future health.”
The study was a collaboration among researchers at Karolinska Institutet, Bristol University (UK) and Sun Yat-Sen University (China).
Scanning Electron Micrograph of Pseudomonas aeruginosa. Credit: CDC/Janice Carr
Pseudomonas aeruginosa bacteria are a common menace in hospital wards, causing life-threatening infections, and are often resistant to antibiotics. Researchers have discovered a mechanism that likely contributes to the severity of P. aeruginosa infections, which could also be a target for future treatments. The results were recently appeared in the journal EMBO Reports.
Many bacterial species use sugar-binding molecules called lectins to attach to and invade host cells. Lectins can also influence the immune response to bacterial infections. However, these functions have hardly been researched so far. A research consortium led by Prof Dr Winfried Römer at the University of Freiburg and Prof Dr Christopher G. Mueller at the CNRS/University of Strasbourg has investigated the effect of the lectin LecB from P. aeruginosa on the immune system. It found that isolated LecB can render immune cells ineffective: The cells are then no longer able to migrate through the body and trigger an immune response. The administration of a substance directed against LecB prevented this effect and led to the immune cells being able to move unhindered again.
LecB blockades immune cells
As soon as they perceive an infection, cells of the innate immune system migrate to a nearby lymph node, where they activate T and B cells, triggering a targeted immune response. LecB, according to the current study, prevents this migration. “We assume that LecB not only acts on the immune cells themselves in this process, but also has an unexpected effect on the cells lining the inside of the blood and lymph vessels,” Römer explains. “When LecB binds to these cells, it triggers extensive changes in them.” Indeed, the researchers observed that important structural molecules were relocated to the interior of the cells and degraded. At the same time, the cell skeleton became more rigid. “The cell layer thus becomes an impenetrable barrier for the immune cells,” Römer said.
An effective agent against LecB
Can this effect be prevented? To find out, the researchers tested a specific LecB inhibitor that resembles the sugar building blocks to which LecB otherwise binds. “The inhibitor prevented the changes in the cells, and T-cell activation was possible again,” Mueller said. The inhibitor was developed by Prof Dr Alexander Titz, who conducts research at the Helmholtz Institute for Pharmaceutical Research Saarland and Saarland University.
Further studies are needed to determine how clinically relevant the inhibition of the immune system by LecB is to the spread of P. aeruginosa infection and whether the LecB inhibitor has potential for therapeutic application. “The current results provide further evidence that lectins are a useful target for the development of new therapies, especially for antibiotic-resistant pathogens such as P. aeruginosa,” the authors conclude.
Canadian and UK researchers explored the relationship between vitamin D supplementation and dementia in more than 12 388 participants of the US National Alzheimer’s Coordinating Center, who had a mean age of 71 and were dementia-free when they signed up.
The team found that taking vitamin D was associated with living dementia-free for longer, and they also found 40% fewer dementia diagnoses in the group who took supplements.
Of the group, 2696 participants progressed to dementia over ten years; amongst them, 2017 (75%) had no exposure to vitamin D throughout all visits prior to dementia diagnosis, and 679 (25%) had baseline exposure.
Professor Zahinoor Ismail, of the University of Calgary and University of Exeter, who led the research, said: “We know that vitamin D has some effects in the brain that could have implications for reducing dementia, however so far, research has yielded conflicting results. Our findings give key insights into groups who might be specifically targeted for vitamin D supplementation. Overall, we found evidence to suggest that earlier supplementation might be particularly beneficial, before the onset of cognitive decline.”
While Vitamin D was effective in all groups, the team found that effects were significantly greater in females, compared to males. Similarly, effects were greater in people with normal cognition, compared to those who reported signs of mild cognitive impairment – changes to cognition which have been linked to a higher risk of dementia.
The effects of vitamin D were also significantly greater in people who did not carry the APOEe4 gene, known to present a higher risk for Alzheimer’s dementia, compared to non-carriers. The authors suggest that people who carry the APOEe4 gene absorb vitamin D better from their intestine, which might reduce the vitamin D supplementation effect. However, no blood levels were drawn to test this hypothesis.
Previous research has found that low levels of vitamin D are linked to higher dementia risk. Vitamin D is involved in the clearance of amyloid in the brain, the accumulation of which is one of the hallmarks of Alzheimer’s disease. Studies have also found that vitamin D may provide help to protect the brain against build-up of tau, another protein involved in the development of dementia.
Co-author Dr Byron Creese, at the University of Exeter, said: “Preventing dementia or even delaying its onset is vitally important given the growing numbers of people affected. The link with vitamin D in this study suggests that taking vitamin D supplements may be beneficial in preventing or delaying dementia, but we now need clinical trials to confirm whether this is really the case. The ongoing VitaMIND study at the University of Exeter is exploring this issue further by randomly assigning participants to either take vitamin D or placebo and examining changes in memory and thinking tests over time.”
People undergoing hormone replacement therapy (HRT) for gender dysphoria have a greatly increased risk of serious cardiac events, according to a study presented at the American College of Cardiology annual meeting. Compared to people with gender dysphoria not taking HRT, those taking HRTY saw a seven-fold risk increase for ischaemic stroke, and risk increases for myocardial infarction and pulmonary embolism.
People with gender dysphoria may use HRT as part of gender affirmation therapy to transition to a different gender than their biological sex at birth. HRT for this purpose is rapidly increasing, especially among teens and young adults.
Previous research on hormone-modulating medications has primarily focused on younger women using hormone-based birth control or on older women following a hysterectomy or during menopause. In these populations, long-term HRT has been associated with an increased risk of breast cancer, stroke and blood clots.
Researchers retrospectively examined rates of cardiovascular events in over 21 000 people with gender dysphoria from a national database of hospital records, of whom 1675 had used HRT. Typically, people assigned male at birth receive oestrogen and people assigned female at birth receive testosterone. Overall results found hormone replacements were associated with higher rates of cardiac events, mostly related to dangerous blood clots, but were not associated with higher rates of death.
Compared with hospitalised patients with gender dysphoria who had never used HRT, those taking gender affirmation HRT had higher rates for a range of in-hospital cardiovascular events:
ST-elevation myocardial infarction (OR 5.90, 95% CI 1.07-32.42)
Ischaemic cerebrovascular accident (OR 7.15, 95% CI 2.74-18.67)
Non-ST-elevation myocardial infarction (OR 3.30, 95% CI 1.20-9.04)
Pulmonary embolism (OR 4.92, 95% CI 2.08-11.62)
“It’s all about risks and benefits. Starting transitioning is a big part of a person’s life and helping them feel more themselves, but hormone replacement therapy also has a lot of side effects – it’s not a risk-free endeavour,” said Ibrahim Ahmed, MD, a third-year resident at Mercy Catholic Medical Center in Darby, Pennsylvania and the study’s lead author.
HRT was not associated with any increase in deaths, incident atrial fibrillation, diabetes, hypertension, haemorrhagic stroke, or heart failure.
Both oestrogen and testosterone are known to increase the clotting activity of blood, which could explain the increase in clotting-related cardiovascular events, researchers said. Those taking hormone replacement therapy also had higher rates of substance use disorder and hypothyroidism.
“Looking at a person’s medical and family history should definitely be part of the screening protocol before they even start hormone replacement therapy,” Ahmed said. “It is also important that people considering this therapy are made aware of all the risks.”
One limitation of the study is that it only accounted for whether individuals had ever used any type of hormone replacement therapy. To better inform clinical decisions, researchers said it would be helpful to assess whether the duration of treatment, the age at which it is initiated or the type of hormone therapy used affects the risks.
“I’m curious to see if the method of administration alters the outcomes,” Ahmed said. “Is one way of giving hormone replacement therapy better or associated with a lower risk of cardiovascular outcomes? If so, then that should be the focus for how we give these patients their hormone replacement therapy going forward.”
In addition to considering ways to mitigate potential cardiovascular risks before starting hormone replacement therapy for individual patients, researchers said it will be important to continue to study potential long-term cardiovascular and other health effects of gender affirmation therapies as the use of these therapies become more common.
An international Task Force has recommended a method to help diagnose preschool age children with Primary Ciliary Dyskinesia (PCD), a rare, inherited condition that leads to chronic lung, ear and sinus infections. The Task Force’s findings were published in the European Respiratory Journal.
Children with PCD have a problem with mucus build-up, which leads to inflammation in the airways and infections in the lungs, nose, sinuses and ears. Most people with PCD have symptoms from birth or early childhood. But some children with PCD may not be diagnosed until much later.
Currently, a commonly used diagnostic test for PCD is measuring the nitric oxide (nNO) in the nose using a chemiluminescent analyser. This involves holding a sampling tube at the nostril, whilst the patient either holds their breath, or breathes out through their mouth against a resistance – but for young children such controlled breathing isn’t always practical. Furthermore, chemiluminescence analysers are extremely expensive, not portable, and not available in most countries.
Jane Lucas, Professor of Paediatric Respiratory Medicine at University of South Hampton, led an international Task Force to review existing studies and literature to establish whether there were more effective and accessible methods of diagnosis for PCD in younger children.
The task force concluded that although holding the breath or breathing against a resistor whilst using a chemiluminescence analyser was more reliable in older children and adults, adequate measurements could be achieved by measuring nasal nitric oxide whilst a pre-school child breathes normally and should be the standard way when diagnosing PCD in children under the age of five.
The Task Force also suggested that although chemiluminescence analysers are more reliable, the relatively inexpensive electrochemical devices have a role in healthcare systems with limited resources. They also recognised that the portability of electrochemical devices may be useful in countries where patients live long distances from a specialist centre, enabling the specialist to travel to the patient.
“We know that the earlier we can diagnose a condition, the better the chances are of implementing the best treatment plan for the patient,” Professor Lucas said. “But current guidelines and technical standards focus on nNO measurements in older, cooperative children using technology that is not widely available.
“Pre-schoolers often need different methods to be employed when measuring nNO, methods that are less invasive and adaptable. Without guidelines for younger children, and electrochemical analysers there is huge variability in how people take the measurements and interpret them.
“This paper is the first step towards standardising sampling, analysis, and reporting of nNO measured as part of the diagnostic testing for PCD in all age groups including preschool-age children. We hope this will promote earlier diagnosis of PCD, and a standardised approach to interpreting and reporting results.”
The task force also recommends that future research is needed to ensure the technical standard is kept up to date.
According to a new study published in Acta Obstetricia et Gynecologica Scandinavica, in women with uncomplicated pregnancies, elective induction of labour at any point between 37 and 41 weeks was consistently associated with those children having lower scholasti performance at age 12.
Investigators analysed data for 266 684 children born between 37 and 42 weeks from uncomplicated pregnancies in white women in the Netherlands. Scholastic performance scores at age 12 years were lower in those from pregnancies with induced labour at 37–41 weeks compared with those with uninduced labour. At 42 weeks, there was no significant difference in scholastic performance between these groups.
The proportion of children who reached higher secondary school level was significantly lower after induction of labour at each gestational week from 38–41 weeks. For example, at 38 weeks, rates were 48% versus 54% in induced versus uninduced. (In the Dutch education system, when children reach the end of primary school, around 12 years of age, they are divided over four different levels of secondary education according to their intellectual ability. All children in the last year of regular primary education take a test to guide the choice of level of secondary education.)
“Of course, if there is an indication to induce delivery before 41 weeks, there is little doubt we should do this. But if the reason is purely elective, it is reasonable to be cautious of these subtle adverse effects,” said Wessel Ganzevoort, MD, PhD, senior investigator and maternal foetal medicine specialist at Amsterdam UMC.
By Yanga Nokhepheyi, Marlise Richter, and Fatima Hassan for Spotlight
A frightful piece of information came to light recently. The pharmaceutical giant Pfizer announced its 2022 revenue at $100 billion. This is more than the combined health spending of 108 countries in 2020 according to calculations of The People’s Vaccine Campaign. The Pfizer COVID vaccine, of course, helped the dollars roll in. In fact, some reports suggest that Pfizer charged some countries $130 per dose of vaccine, while it is estimated that it costs less than $2 per dose to make. That equated to a markup of a stupefying 10 000% but we don’t know the full pricing details because the contracts are marked ‘secret’.
Figures like these make one’s eyes water.
In this pandemic, tackling the pharmaceutical sector and the perversities of its pandemic profiteering has been the focus of an international movement of health activists united under the banner of the People Vaccine Campaign. Partly because of severe resistance by governments in the global north and inaction locally, access to timely supplies of affordable and essential COVID vaccines, medicines and diagnostics has not materialised. But the struggle continues not only to tackle these structural barriers to beat COVID and future pandemics but also to help ensure implementation of Universal Health Coverage (UHC) systems. UHC means that everyone would be able to get the quality health services they need and benefit from scientific progress – irrespective of their ability to pay and without having to face financial hardship.
A Herculean task
South Africa, too, has committed to attaining UHC by 2030 as part of a set of promises made on the United Nation’s Sustainable Development Goals. South Africa’s main strategy to attain UHC is to implement a National Health Insurance (NHI) system. Unfortunately, progress has been historically slow, but in the build-up to the 2024 elections, the African National Congress (ANC) Members of Parliament (MPs) are rushing the law reform process despite an acknowledgement even from the health ministry that progress and timelines are hampered by the socio and mainly economic impacts of the pandemic. This includes a fiscus crisis with additional pandemic-related debt, and according to Dr Nicholas Crisp, Deputy Director-General in the health department responsible for NHI, “the NHI could take decades to be implemented at full scale”.
It will require a Herculean task to unify our apartheid-era two-tiered healthcare system, with the right skills, funding base, and transparency in decision-making around health policy and medicine selection. The pandemic has highlighted why all these elements are critical for healthcare for everyone.
We provide a short overview of our research below.
Law reform
Last year, the Portfolio Committee on Health in Parliament deliberated on the ‘NHI Bill’, but there were no significant changes made to it. It needs major revision. Many serious concerns and recommendations from parliamentary submissions by multiple stakeholders have gone unaddressed. The Health Justice Initiative (HJI) has focused on medicine procurement provisions in the Bill and in 2022 raised at least 17 questions that require greater attention before the law is passed. Neglecting to address the public’s submissions is not surprising seeing that ANC MPs serving on the committee were resolute in having the National Assembly adopt the Bill before the ANC Conference in December 2022. However, time ran out before the adoption of the Bill by Parliament, and the Parliamentary process is seemingly going to resume this month.
Stakeholder submissions to Parliament on the Bill (of which there were 64 000 written submissions following Parliament’s call for comment in 2019) and various commentators have warned about the ‘looming disaster’ that the Bill in its current form poses, but they are often divided on the main reasons. A tiny minority resists the principle of unified health systems and Universal Health Care for all (meaning, also for the poor). Many more groups agree that NHI is an ethical necessity but are concerned about South Africa’s disintegrating public health system, energy crisis, high levels of state corruption involving health product procurement, and the in/ability of the Department of Health to actually implement NHI in its current proposed form.
Other groups have rightfully pointed out concerns over conferring too much power on the Minister of Health, inadequate financing models, the feasibility of NHI in SA post-COVID, and the exclusion of specific categories of people from NHI. (For a curated archive of critical submissions, please see here).
Risks to medicine access
Regrettably, the provisions in the Bill on Medicine Selection, Pricing, and Procurement are ambiguous at best, and as the HJI pointed out in 2022, the entire shift of our medicine selection, procurement, and reimbursement system to “NHI reimbursement” has not been adequately thought through, potentially posing a great risk for the future of medicine selection and access in the country for all people. This requires immediate attention at the highest levels of the executive and the legislature too – and likely needs a multi-department and stakeholder technical group to urgently determine the exact trajectory of this planned process.
The World Health Organization has emphasised that UHC programmes will only be successful if there is “affordable access to safe, effective, and quality medicines and health products”. In addition, the COVID pandemic has taught us that timely and fairly priced access to essential diagnostics, therapeutics, and vaccines is key to addressing any public health emergency and improving health outcomes. We cannot safeguard public health without access to medicines – procured fairly, delivered on time, and based on expert and transparent decision-making and approval.
The cost of medicine, as elsewhere in the world where there are national health systems, remains a key concern. The Minister of Health last November in the National Assembly said that the funds for the NHI would be collected through a combination of taxes, including the reallocation of medical scheme credits paid to medical schemes, provincial health budgets to the NHI Funds, and payroll tax.
The financial feasibility of implementing the NHI is still unclear and a huge risk to the fiscus in a post-COVID economy that is dealing with a recession, load shedding, and high unemployment rates.
In late 2022, HJI argued that the Bill does not adequately consider the complexities of medicines access and that our medicines system could be severely jeopardised if poorly drafted sections in the current Bill become law. We said that government should set up a task team to urgently determine the exact trajectory of this planned process.
The Health Department’s recent response to submissions and its own recommendations on amendments to the Bill sadly does not realise the gravity of the threat to the future of medicine selection and access.
17 questions
In HJI’s 2022 analysis of the Bill, we raised 17 key questions that we believe must be addressed by lawmakers in the next version of the Bill and before NHI comes into effect. These include:
What specific measures are envisaged to enable and promote public transparency related to medicine selection, procurement, and contracting processes under the NHI?
How will the price of medicines not included in or covered by the NHI be regulated? And what role will External Reference Pricing (ERP) methodology play in the NHI and beyond?
How will the NHI Fund (e.g., the Office of Health Products Procurement, the NHI Board) negotiate with global pharmaceutical manufacturers and suppliers to procure for government and how will that process be transparent and accountable?
How will the Minister determine that the NHI is ‘fully implemented’, and what will take place in terms of what medical schemes can and cannot offer members during the transition period, and after the (undefined) date?
Has consideration been given to designing a competitive and different single medicine pricing system for SA?
Drawing on our work on medicine access during the HIV and COVID pandemic, we appreciate that there are powerful vested interests located in the multi-trillion-dollar pharmaceutical industry – this is why there is a need for legal safeguards, sound legislation, and independent and transparent institutions to ensure access to affordable medicines for all of us living here.
The pandemic showed that a lack of transparency, autonomy, and information around expert advice can bedevil open government decision-making. Secret procurement contracts for essential vaccines could become the norm even under NHI as they did in COVID, something we are fighting in our courts to open up, later this year.
Figuring out a sound system for a unified medicine access system under NHI is a formidable undertaking that requires a multi-disciplinary task team with experts from various fields, experience, and technical know-how. It is not easy to simply merge two parallel medicine procurement and selection systems. The risk is that the status quo could continue – where the rich and insured access the best medicines at a higher price.
We believe that the principles underpinning NHI for our highly regressive, unequal two-tiered healthcare system are too important for our collective health, well-being, and our Constitutional democracy to have lacklustre legal provisions and worrying gaps on the essential issues of medicine procurement and selection.
As the Bill currently stands, it will strengthen the private healthcare sector’s stranglehold on us and our fiscus. It will leave us at the mercy of advisory committees that bear no duty to be transparent in deciding which medicines you and I will be able to access under NHI.
We can and need to do better.
* Nokhepheyi and Richter are researchers and Hassan the Director of the Health Justice Initiative.
